Sleep DisturbanceNCT05821049
A Study to Evaluate the Efficacy of UP165 on Sleep Quality and Mood State in Healthy Adults
A study testing UPI65 (Low Dose) and UP165 (High Dose) in people with Sleep Disturbance, run by Vedic Lifesciences Pvt. Ltd. at 6 sites in India.
Trial summary
A randomized, double blind, placebo controlled, parallel group study to evaluate the efficacy of UP165 on sleep quality and mood state in healthy adults Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- UPI65 (Low Dose) and UP165 (High Dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 6 sitesIndia
- Study dates
- 4 May 2023to 8 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects ≥20 and ≤ 60 years' old with moderate physical activity level as per International Physical Activity Questionnaire - Short Form(IPAQ - SF)
- Volunteers with body mass index between 18.5 and 29.9 kg/m2. Fairly bad or very bad subjective sleep quality with a score of 2 or 3 assessed as per PSQI Q9.
- Willing to maintain current dietary pattern, activity level, and stable bodyweight for the duration of the study, and refrain from any drastic lifestyle changes.
- Unable to fall asleep or unable to stay asleep (2 or more waking episodes during sleep at least twice a week but not more than four times)
- Agrees to maintain current sleep schedule throughout the study
- Agrees to stay in the current time zone for the duration of the study
- Subjects ready to give voluntary, written, informed consent to participate in the study.
- Willing to complete all study procedures including study-related questionnaires and comply with study requirements.
Who cannot join
- Subjects diagnosed with sleep disorders secondary to another health problem.
- Consumption of hypnotic drugs (<3 months before inclusion).
- Subjects with a history of caffeine consumption post 6:00 pm.
- Individuals taking any other sleep supplements and are unwilling to stop taking those supplements for the duration of the study period
- Recent history of physical, emotional, social trauma within last three months.
- Participants who are not medication (which are likely to impact sleep quality or pattern) free for at least 4 weeks apart from contraceptive pills
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- Subjects who consume pain-relieving medications more than once per week.
- Individuals who have night terrors regularly
- Individuals who regularly sleepwalk
- Individuals who work at night shifts.
- Individuals who have regular bad dreams
- Use of the following medications during the study period: oral or injectable corticosteroid, sedating antihistamines (e.g. cold, allergy, motion sickness), psychotropic medications or hypnotics, benzodiazepine, narcotics, any illicit drugs
- Gastro-intestinal, hepatic, respiratory, psychiatric, kidney, or cardiovascular disorder (<3 months before inclusion),
- Recent (<3 months before inclusion) change in lifestyle (food, body weight, sport, drug, and/or dietary supplement),
- Students having regular class and assignments
- Subjects addicted to digital media who exhibit at least five of the following symptoms currently:
- Preoccupation with the digital media use j) Withdrawal symptoms that occur when digital media use is not possible k) Build-up of a tolerance that requires increasing amounts of digital media use to satisfy cravings l) Unsuccessful attempts to stop or limit digital media use m) Replacement of previously pleasurable activities with digital media use n) Unwillingness to stop digital media use despite its negative consequences o) Being deceptive about digital media use p) Using digital media use as a coping mechanism
- Addiction or history of substance abuse,
- Consumption of more than 3 glasses of alcohol per day,
- Pregnant or lactating woman,
- Lifestyle habits which would modify the wake-sleep rhythm, or which was expected to be modified during the study period (e.g., night work), and finally,
- Known allergy to the IP.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
V.S. General Hospital
Ahmedabad, Gujarat, 380006
Poojan Multispeciality Hospital
Ahmedabad, Maharashtra, 380061
Shree Ashirwad Hospital
Dombivali, Maharashtra, 421201
Maharaja Agrasen Superspeciality Hospital
Jaipur, Rajasthan, 302039
Sai Cititcare
Ulhasnagar, Maharashtra, 421004
Aman Hospital and Research Center
Vadodara, Gujarat, 390021
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy of UP165 on Sleep Quality and Mood State in Healthy Adults
A randomized, double blind, placebo controlled, parallel group study to evaluate the efficacy of UP165 on sleep quality and mood state in healthy adults
- Conditions
- Sleep Disturbance
- Being tested
- UPI65 (Low Dose), UP165 (High Dose), Placebo
- Keywords
- Sleep Quality
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPI65 (Low Dose)Other
Red colored Capsules
UP165 (High Dose)Other
Red colored Capsules
PlaceboOther
Red colored Capsules
| Study group | Role | What they receive |
|---|---|---|
| UPI65 (Low Dose) | Active comparator | One capsule to be taken 60 ± 10 mins before bed Receives: Other: UPI65 (Low Dose) |
| UPI65 (High Dose) | Active comparator | One capsule to be taken 60 ± 10 mins before bed Receives: Other: UP165 (High Dose) |
| Placebo | Placebo comparator | One capsule to be taken 60 ± 10 mins before bed Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of the Investigational Product (IP) from baseline on
Sleep statistics (sleep quality thoughout the study) by using the watch known as Garmin vivosmart 4 Tracker. This watch will be used to measure the deep sleep, REM sleep and wake-up time in hours.
Measured: throughout the study period (approximately 28 days)
To assess the efficacy of the Investigational Product (IP) from baseline on
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
Measured: Day 28
To assess the efficacy of the Investigational Product (IP) from baseline on
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
Measured: Day 21
To assess the efficacy of the Investigational Product (IP) from baseline on
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
Measured: Day 14
To assess the efficacy of the Investigational Product (IP) from baseline on
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
Measured: Day 7
To assess the efficacy of the Investigational Product (IP) from baseline on
Mood using POMS-A (Profile of Moods States - Abbreviated version)
Measured: Day 28
To assess the efficacy of the Investigational Product (IP) from baseline on
Mood using POMS-A (Profile of Moods States - Abbreviated version)
Measured: Day 21
To assess the efficacy of the Investigational Product (IP) from baseline on
Mood using POMS-A (Profile of Moods States - Abbreviated version)
Measured: Day 14
To assess the efficacy of the Investigational Product (IP) from baseline on
Mood using POMS-A (Profile of Moods States - Abbreviated version)
Measured: Day 7
To assess the efficacy of the Investigational Product (IP) from baseline on
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
Measured: Day 28
To assess the efficacy of the Investigational Product (IP) from baseline on
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
Measured: Day 21
To assess the efficacy of the Investigational Product (IP) from baseline on
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
Measured: Day 14
To assess the efficacy of the Investigational Product (IP) from baseline on
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start4 May 2023
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double blind, placebo controlled, parallel group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821049
- Sponsor's protocol ID
- UI/220902/UP/SQMS
- Status last verified
- Apr 2024
- First submitted
- 23 Mar 2023
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy of UP165 on Sleep Quality and Mood State in Healthy Adults
- ClinicalTrials.gov ID
- NCT05821049
- Acronym / sponsor ID
- UI/220902/UP/SQMS
- Conditions
- Sleep Disturbance
- Keywords
- Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 May 2023 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double blind, placebo controlled, parallel group study to evaluate the efficacy of UP165 on sleep quality and mood state in healthy adults
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- A randomized, double blind, placebo controlled, parallel group
| Arm | Type | Receives |
|---|---|---|
| UPI65 (Low Dose) | Active comparator | Other: UPI65 (Low Dose)One capsule to be taken 60 ± 10 mins before bed |
| UPI65 (High Dose) | Active comparator | Other: UP165 (High Dose)One capsule to be taken 60 ± 10 mins before bed |
| Placebo | Placebo comparator | Other: PlaceboOne capsule to be taken 60 ± 10 mins before bed |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and female subjects ≥20 and ≤ 60 years' old with moderate physical activity level as per International Physical Activity Questionnaire - Short Form(IPAQ - SF)
- Volunteers with body mass index between 18.5 and 29.9 kg/m2. Fairly bad or very bad subjective sleep quality with a score of 2 or 3 assessed as per PSQI Q9.
- Willing to maintain current dietary pattern, activity level, and stable bodyweight for the duration of the study, and refrain from any drastic lifestyle changes.
- Unable to fall asleep or unable to stay asleep (2 or more waking episodes during sleep at least twice a week but not more than four times)
- Agrees to maintain current sleep schedule throughout the study
Key exclusion criteria (22 listed)
- Subjects diagnosed with sleep disorders secondary to another health problem.
- Consumption of hypnotic drugs (<3 months before inclusion).
- Subjects with a history of caffeine consumption post 6:00 pm.
- Individuals taking any other sleep supplements and are unwilling to stop taking those supplements for the duration of the study period
- Recent history of physical, emotional, social trauma within last three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UPI65 (Low Dose)Red colored Capsules | Other | UPI65 (Low Dose) |
| UP165 (High Dose)Red colored Capsules | Other | UPI65 (High Dose) |
| PlaceboRed colored Capsules | Other | Placebo |
Primary outcome
To assess the efficacy of the Investigational Product (IP) from baseline on
Time frame: throughout the study period (approximately 28 days)
Sleep statistics (sleep quality thoughout the study) by using the watch known as Garmin vivosmart 4 Tracker. This watch will be used to measure the deep sleep, REM sleep and wake-up time in hours.
To assess the efficacy of the Investigational Product (IP) from baseline on
Time frame: Day 28
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
To assess the efficacy of the Investigational Product (IP) from baseline on
Time frame: Day 21
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
To assess the efficacy of the Investigational Product (IP) from baseline on
Time frame: Day 14
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
To assess the efficacy of the Investigational Product (IP) from baseline on
Time frame: Day 7
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
To assess the efficacy of the Investigational Product (IP) from baseline on
Time frame: Day 28
Mood using POMS-A (Profile of Moods States - Abbreviated version)
To assess the efficacy of the Investigational Product (IP) from baseline on
Time frame: Day 21
Mood using POMS-A (Profile of Moods States - Abbreviated version)
To assess the efficacy of the Investigational Product (IP) from baseline on
Time frame: Day 14
Mood using POMS-A (Profile of Moods States - Abbreviated version)
To assess the efficacy of the Investigational Product (IP) from baseline on
Time frame: Day 7
Mood using POMS-A (Profile of Moods States - Abbreviated version)
To assess the efficacy of the Investigational Product (IP) from baseline on
Time frame: Day 28
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
To assess the efficacy of the Investigational Product (IP) from baseline on
Time frame: Day 21
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
To assess the efficacy of the Investigational Product (IP) from baseline on
Time frame: Day 14
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
To assess the efficacy of the Investigational Product (IP) from baseline on
Time frame: Day 7
Salivary cortisol levels immediately after waking up in the morning (before doing any activity)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UPI65 (Low Dose) and UP165 (High Dose) in people with Sleep Disturbance, run by Vedic Lifesciences Pvt. Ltd. at 6 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of the Investigational Product (IP) from baseline on (time frame: throughout the study period (approximately 28 days)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.